In-dwelling port for access into a body

ABSTRACT

An in-dwelling port for providing repeated entry to a body during and/or after an operation is described. The port may include an external portion secured to a body outside an incision and a collapsible insertion portion that is inserted through the incision. The collapsible portion collapses when no instrument or lumen is present to permits the body to return to substantially a normal profile around the incision.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the benefit of U.S. Application No. 60/835,566filed Aug. 4, 2006 and the entirety of that application is incorporatedherein by reference.

TECHNICAL FIELD

This application relates to medical devices for use in surgicalapplications. More specifically, this application relates to ports foruse in accessing an area of a body during and/or after a surgicalprocedure.

BACKGROUND

In minimally invasive surgical procedures, such as laparoscopicprocedures, one or more small incisions are made in a body to allowaccess for the necessary surgical tools. If there is a need to re-enterthe body after a surgical procedure, a mechanism for doing so must beput in place. For targeted or prophylactic chemotherapy, post-operativeapplications of a substance can be made by re-instituting an environmentin the patient in which subsequent applications of the substance may bemade. This may be accomplished by leaving a port device in the patientafter the surgical procedure, or by surgically placing a port in thepatient in preparation of a non-surgical treatment regimen.

The port may be a device capable of providing a sanitary access point toa body, where the device is a resealable mechanism that attaches to theexterior of the skin and the interior wall of the skin. The port permitsa device for applying a substance to the body to be reconnected to thepatient at a later time to apply the substance or other treatment. Oneexample of this type of port is an enteral feeding tube port.

The design of re-entry ports typically focuses on semi-rigid tubes, suchas feeding ports which are meant to transverse from out side the bodyinto an organ such as the stomach. These devices often have a bulb orprotrusion at the insertion end to maintain the location of the tube inthe organ being accessed, and consist of a rigid or semi-rigid tube orlumen. Catheters, such as urethral catheters for access into the bladdertend to be flexible catheters, usually with a balloon or some type ofprotrusion that is used to anchor the catheter into the organ to preventits movement back through the body channel. Intravenous ports, ports orneedles that are inserted into a vein, are generally taped or perhapssutured in place to prevent the accidental removal of the device. Otherdevices such as flat tubes with holes, sometimes under suction have beenused as drains for wounds or to prevent fluid build up in the chestcavity.

SUMMARY

An improved port is described below that can remain in place, forexample between physical structures such as the abdominal wall and theorgans below, or in the plural cavity between the ribs and the lungs, orin any other physical location where the separation of bodily spaces maybe required on a recurring basis.

According to a one aspect, an in-dwelling port is described having anexternal portion or flange configured for placement outside of anincision and defining a proximal port opening. A collapsible insertionportion having a distal port opening is attached to the external portionand positioned in a substantially coaxial relationship to the proximalport opening. The collapsible insertion portion is repeatably adjustablebetween an elongated position, where the collapsible insertion portiondefines an elongated length and an elongated width, and a collapsedposition, where the collapsible portion defines a collapsed length and acollapsed width. The elongated length is greater than the collapsedlength and the elongated width is less than the collapsed width to allowfor easy insertion, firmer placement in a collapsed position, and a lessintrusive and disruptive way of leaving a port in a body when the portis not in use.

Other features and advantages of the invention will become apparent uponreview of the following drawings, detailed description and claims

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an in-dwelling port in an elongatedposition.

FIG. 2 is a top plan view of the in-dwelling port of FIG. 1.

FIG. 3 is a cross-sectional side view of the port of FIG. 1.

FIG. 4 is a cross-sectional side view of the port of FIG. 1 in acollapsed position.

FIG. 5. is a side view of a stylus suitable for use in inserting theport of FIG. 1 into an incision.

FIG. 6 is a top plan view of an alternative embodiment of thein-dwelling port of FIG. 1.

FIG. 7 is a cross-sectional side view of the port of FIG. 6 in anelongated position.

FIG. 8 is a top plan view of a second alternative embodiment of thein-dwelling port of FIG. 1.

FIG. 9 is a cross-sectional side view of the port of FIG. 8 in anelongated position.

FIG. 10 is a top plan view of a third alternative embodiment of thein-dwelling port of FIG. 1.

FIG. 11 is a cross-sectional side view of the port of FIG. 10 in anelongated position.

FIG. 12 is a perspective view of the port of FIG. 11.

FIG. 13 is a top plan view of a fourth alternative embodiment of thein-dwelling port of FIG. 1.

FIG. 14 is a cross-sectional side view of the port of FIG. 13 in anelongated position.

FIG. 15 is a cross-sectional side view of a fifth alternative embodimentof the port of FIG. 1 in an elongated position.

FIG. 16 is a cross-sectional side view of the port of FIG. 15 in acollapsed position.

DETAILED DESCRIPTION

FIGS. 1-4 illustrate one version of an in-dwelling port 10 whereseparation of body spaces may be required on a recurring basis. Thisin-dwelling port 10 may be used to reinflate the space between theabdominal wall and the organs below (peritoneal cavity). The port 10includes an outer flange 12 and a collapsible insertion portion 14. Theouter flange 12 may have a greater diameter than that of the collapsibleinsertion portion 14 to stabilize the port in the patient and preventover-insertion into an incision. A proximal port opening 16 is definedby the flange 12 to allow one or more lumens or medical devices accessinto the collapsible insertion portion 14. A distal port opening 18 ispositioned at the end of the collapsible insertion portion 14 andpermits access to the body cavity.

A replaceable plug 20 is removably insertable into the proximal portopening to prevent an infection or other foreign substances to enter thebody when the in-dwelling port 10 is not in use. The plug 20 may beattached to the outer flange 12 by a tether 22. The tether may be formedfrom the same piece of material as the outer flange, or it may be aseparate material attached to the outer flange 14. The plug may be acompression-style plug that is elastic enough to fill the proximal portopening 16 when pressed in place. Alternatively, the plug 20 may be adiscrete component unattached by a tether. Any of a number of otherfastening means, such as threaded ends, collapsible detents or othermechanisms may also be used to connect the plug and the proximal portopening.

The outer flange may include recessed regions 24 on one or more sides.The recessed regions may be sized to provide an anchor for sutures,adhesives or other devices for holding the in-dwelling port in place onthe body. The outer flange may also be held in place by having anoptional adhesive surface to keep it against the skin. The adhesivesurface may be islands of adhesive positioned about the underside of theflange. Alternatively, to provide a more complete seal and to helpprevent deterioration of the tissue through which the in-dwelling portis inserted, a continuous ring of adhesive or adhesive material may bepositioned on the underside of the flange to prevent tearing andstrengthen the integrity of the tissue surface. Thus, the in-dwellingport 10 may be affixed in a number of ways, individually orcollectively, by suturing the recessed regions of the flange, adheringthe underside of the flange to the outer tissue surface, and evencovering the flange with an adhesive bandage (regular and medicated) tohelp keep it in place and to further help resist infection.

The collapsible insertion portion 14 of the in-dwelling port 10 may befabricated in any manner that permits it to collapse when not in use,for example in the form of a bellows or accordion-like structure. Oncepast the abdominal wall or other body structure, it can gently collapseback to an almost flat shape. The flat shape may assist in reducingirritation and trauma, as well as provide very little restriction tonormal body motion and limited visibility of its presence. A feature ofthe bellows structure of the collapsible insertion portion is that itwill present a reduced diameter when elongated and may more easily gothrough a relatively small incision or wound site, or even a naturalbody passage way. Once in place, the structure will allow thecollapsible insertion portion to collapse into a larger diameter so asnot to work itself out of the incision, wound, or body passage.Referring to FIG. 4, the collapsed state of the in-dwelling port expandsthe bellows portion to hold, for example, the abdomen wall between theflange 12 and the collapsible insertion portion 14 for a secure andlow-profile point of re-entry.

Referring to FIG. 5, a stylus 26 is designed to fit in the collapsibleinsertion portion 14 via the proximal port opening 16 and extend thein-dwelling port 10 to its smallest diameter for insertion into anincision. If, for example, the in-dwelling port was intended forinsertion into an abdomen wall, the stylus would first be inserted intothe proximal port, extending the collapsible insertion portion and thusreducing its diameter. The distal port opening 18 may be provided with asmaller diameter than the proximal port opening 16 so that the stylus 26remains in the collapsible insertion portion during insertion. Aphysician may then push the in-dwelling port into position from outsidethe abdomen wall and into the peritoneum, for example via a trocar wound(not shown).

Once inserted, and optionally secured at the flange to the abdomen, thestylus 26 would typically be removed and one or more lumens may beintroduced and later reintroduced, through the in-dwelling port. Thein-dwelling port 10 may allow for the insertion of medical devices afterplacement by maintaining one or more access lumens to pass a medicaldevice through it such as a catheter, or a small needle or trocar, anoptical endoscope, an operative instrument or any number of surgical,diagnostic, or palliative devices.

When all lumens in the port 10 are removed and the port is not in use,the collapsible insertion portion will collapse down and allow theabdomen wall to collapse to a more relaxed position that may besubstantially close to its pre-insertion shape. The plug 20 may then beinserted to provide a barrier to contaminants. Having a way to allow theseparation (or re-separation) of the abdominal wall or cavity from theorgans below for purposes of examination, application of medicines, oreven operative tasks is desirable and is usually accomplished byinsufflation of the peritoneal space. Because the port is intended foraccess to the bodily space for the purpose of re-expanding theseparation of one layer or body structure from another the port alsopermits the body structure to return to its substantially normal(collapsed) position.

An alternative embodiment of the in-dwelling port 30 is shown in FIGS.6-7. In this arrangement, a re-sealable membrane 32 is positioned acrossthe proximal port opening 34. A needle or other sharp-ended introducingdevice may be used to pierce the membrane 32 or surface and introduce alumen or instrument through the membrane and subsequently into the bodyvia the distal port opening 36. The membrane would reseal itself afterremoval. This pierceable membrane or cover may be manufactured from anyof a number of materials, for example polysoprene, isoprene or silicone.In an alternative embodiment, the in-dwelling port may have a secondproximal port opening that could be connected to a filter in order torelease pressure from an expanded space, for example the peritoneumduring a laparoscopic procedure, without permitting organisms to bereleased into the air.

In an alternative embodiment shown in FIGS. 8-9, the in-dwelling port 40may have a tear-away seam 44 disposed along the entire length of theport. The seam 44 may traverse the flange 42 and the collapsibleinsertion portion 45 to form a continuous line of perforations from theproximal port opening 46 to the distal port opening 48. In oneembodiment, the seam 44 may be a line of perforations extendinglongitudinally down the device from proximal 46 to distal 28 portopening, multiple parallel lines of perforations to allow for tearingthe indwelling port from one or more sides of the flange 42, or anydesired pattern of perforations to allow segmented destruction andremoval of the indwelling port. In alternative embodiments, the lines ofperforations may be other types of weakened seams defining a continuousline of weakened or reduced thickness material that permit for asubstantially clean tear when a user desires to remove the in-dwellingport.

One advantage of an in-dwelling port as shown in FIGS. 8-9 with atear-away seam is that a new in-dwelling port may be inserted into anold indwelling port already positioned in a body and the old port couldbe removed by splitting and pulling out the old port. Alternatively, theold port could pulled into a sleeve device and removed, the sleeveserving to keep the space open to place a new port in place of the oldport, or even a tool or a finger could be pushed along side the old portwhile a new port is positioned next to the tool or finger, and inserted.

The in-dwelling ports in FIGS. 1-9 are shown with one lumen through thecenter. In other implementations, two or more lumens may be fabricatedso that more than instrument could be inserted into it, or one lumencould be attached to a pressure source such as an insufflator and theother to a suction source, or a commercially available pressure reliefdevice (such as manufactured by Smart products), or a mini-endoscope maybe inserted into one lumen an and instrument or catheter or some otheroperative device may be inserted into another. The device is not limitedto a single useful lumen, and multiple lumens could be utilized withmany other medical devices seeking entry into the body space. Other usesfor the lumen(s) may include applications requiring the insertion of afluid catheter, the use of an aerosolization or nebulizing device forthe purpose of coating or treating organ cavity.

As shown in FIGS. 10-12, an in-dwelling port 50 may be constructed withtwo proximal openings 52 that each lead to a respective half of theinterior of a single collapsible insertion portion 62. Each proximalopening 52 may have its own removable plug 54 attached to the flange 64by respective tethers 56. A collapsible partition 60 extending throughthe interior of the area enclosed by the collapsible insertion portion62 defines two separate access paths 66 terminating at respective distalopenings 58. Although the access paths 66 are shown as equal in size inFIGS. 10-12, access paths of unequal size or more than two paths in thesingle collapsible portion 62 are contemplated as well.

FIGS. 13 and 14 illustrate another version of an in-dwelling port 70 forallowing access for multiple devices such as noted above. In the versionof FIGS. 13-14, two completely separate collapsible insertion portions72 are formed in a single flange member 74. Each collapsible portion hasits own proximal and distal opening 76, 78, where the proximal openings76 may have a greater radius than the distal openings 78 or may becovered with a membrane suitable for piercing by a needle or other sharpinstrument. Additionally, one or both collapsible portions may bepartitioned internally as shown in FIGS. 10-12 to provide separateaccess for even more devices or instruments into a body cavity.

Although the example of in-dwelling ports described above includecollapsible insertion portions, shown as bellows, that are expandableinto a body cavity, there may be a need to insure that the collapsibleinsertion portion or bellows of the device stays up to the distalsurface (i.e. the interior surface) of the tissue or organ into whichthe device is inserted. FIGS. 15-16 illustrate an implementation of anin-dwelling port 80 that allows for the collapsible insertion portion 82to remain secure, and prevent it from “relaxing” or loosening andbecoming partially extended in the bodily cavity. This is accomplishedby having one or more threads or tethers 84 attached to the distalportion of the insertion portion, which can be used to draw-up orretract the collapsible insertion portion 82, either through holes 86 inthe top flange 88, or along the outside of the collapsible insertionportion 82 and the outside(s) of the top flange to be secured by somemeans such as tying, suturing, taping or any other method of securingthe tether(s) 84 in such a way as to keep the collapsible insertionportion 82 collapsed, or loosening them to allow the collapsibleinsertion portion 82 to be expanded. The tethers 84 can be constructedof the same material as the in-dwelling port 80, from thread, or fromany other flexible thin material. It could be accomplished with one ormore such tethers 84. The tethers 84 can be attached to the collapsibleinsertion portion 82 in the molding process, by heat sealing (melting),tying, gluing, or any other method of attaching the tethers to thecollapsible insertion portion of the device.

In yet additional alternative embodiments, where additional rigidity ofthe collapsible insertion portion may be desired, a stylus such as shownin FIG. 5 may include a central bore through which instruments or lumensmay be inserted. Such a modified stylus may remain in the indwellingport during a procedure and removed to allow the in-dwelling port tocollapse when not in use

Any of the in-dwelling port versions described above may be coated orimpregnated with antibacterial and or antimicrobial medications toprevent infection from occurring during its time in place. Such acoating for example could consist of, but is not limited to, Rifamacin,Rifampin, Minocycline, silver sulfadiazine, or Bardex R IC.

The in-dwelling port may be constructed of a resilient material that hasthe ability to reform its shape or accept a “retracted” shape after itis in place. Suitable materials include, but are not limited to,silicone, rubber, latex, nylon, and fabric like materials. Although anynumber of in-dwelling port sizes and dimensions are contemplated, andmay vary depending on intended use, the example shown in FIG. 2 may havea flange major axis length A of 1.75 inches, a flange minor axis lengthB of 0.875 inches, and a tether length C of 0.875 inches. The proximalport opening diameter may be 0.196 inches and the distal port openingmay be 0.112 inches. Accordingly, the stylus used to insert thisspecific version of the in-dwelling port would need to have a minimumdiameter of greater than 0.112 inches and a maximum diameter of lessthan 0.196 inches. Referring again to FIGS. 3 and 4, the collapsibleinsertion portion in this example may have a collapsed depth G of 0.375inches and a maximum extended depth F of 5.0 inches for a greater than 5to 1 ratio. The extended diameter H of the collapsible insertion portionis preferably less than the collapsed diameter I, however the ratio mayvary depending on, for example, the number and length of the folds thatform the bellows or accordion-like structure of the collapsibleinsertion portion.

It is therefore intended that the foregoing detailed description beregarded as illustrative rather than limiting, and that it be understoodthat it is the following claims, including all equivalents, that areintended to define the spirit and scope of this invention.

1-23. (canceled)
 24. An in-dwelling port for permitting access into abody, the port comprising: an external portion configured for placementoutside of an incision, the external portion defining at least twoproximal port openings; a collapsible insertion portion attached to theexternal portion and repeatably adjustable relative to the externalportion between a collapsed position and an extended position, thecollapsible insertion portion defining at least two distal portopenings; and a collapsible partition attached to and extending along aninterior of the collapsible insertion portion, the collapsible partitiondividing the interior into at least two separate access paths, each ofthe at least two separate access paths originating at a respective oneof the at least two proximal port openings and terminating at arespective one of the at least two distal port openings.
 25. The port ofclaim 24, further comprising at least two removable plugs, each of theat least two removable plugs sized to seal a respective one of theproximal port openings.
 26. The port of claim 25, further comprising,for each of the at least two removable plugs, a respective tetherconnected with the plug at a first end and connected with the externalportion at a second end.
 27. The port of claim 24, wherein the externalportion and the collapsible insertion portion each comprise anantimicrobial material.
 28. The port of claim 24, wherein the externalportion and the collapsible insertion portion each comprise a coating ofantimicrobial material.
 29. The port of claim 24, further comprising atear-away seam extending at least a portion of a length of thecollapsible insertion portion and at least a portion of a width of theexternal portion.
 30. The port of claim 24, wherein each of the at leasttwo separate access paths are equal in size.
 31. The port of claim 24,wherein each of the at least two proximal port openings are equal insize.
 32. The port of claim 24, further comprising an adhesivepositioned along an underside of the external portion and configured toadhere to tissue surrounding an incision through which the collapsibleinsertion portion may be inserted.
 33. The port of claim 32, wherein theadhesive comprises a continuous ring of adhesive.
 34. The port of claim24, wherein the external portion further comprises a pierceable surfaceresealably positioned over each of the at least two proximal portopenings.
 35. The port of claim 24, further comprising at least oneretraction tether having a distal end and a proximal end, wherein thedistal end of the retraction tether is connected to a distal portion ofthe collapsible insertion portion and the proximal end is positionedadjacent the external portion of the port and adjustable to retain thecollapsible insertion portion in the collapsible position.
 36. The portof claim 35, wherein the at least one retraction tether is positionedoutside of the collapsible insertion portion.
 37. An in-dwelling portfor permitting access into a body, the port comprising: an externalportion configured for placement outside of an incision, the externalportion defining at least two proximal port openings; a collapsibleinsertion portion attached to the external portion and repeatablyadjustable relative to the external portion between a collapsed positionand an extended position, the collapsible insertion portion defining atleast two distal port openings; a collapsible partition attached to andextending along an interior of the collapsible insertion portion, thecollapsible partition dividing the interior into at least two separateaccess paths, each of the at least two separate access paths originatingat a respective one of the at least two proximal port openings andterminating at a respective one of the at least two distal portopenings; and wherein at least one of the at least two proximal portopenings has a greater diameter than a diameter of at least one of theat least two distal port openings.
 38. The port of claim 37, whereineach of the at least two separate access paths are equal in size. 39.The port of claim 37, wherein each of the at least two proximal portopenings are equal in size.
 40. The port of claim 37, wherein thecollapsible insertion portion comprises a plurality of folds definingflexible bellows positioned along a length of the collapsible insertionportion.
 41. The port of claim 37, wherein the external portion and thecollapsible insertion portion each comprise an antimicrobial material.42. The port of claim 37, further comprising at least one retractiontether having a first end attached to a distal portion of thecollapsible insertion portion and a second end positioned on a side ofthe external portion opposite the collapsible insertion portion, whereinthe at least one retraction tether is movable relative to the externalportion to retract the collapsible insertion portion toward the externalportion.
 43. The port of claim 42, wherein the at least one retractiontether is positioned outside of the collapsible insertion portion.